Corpus callosum neuromodulation assembly

ABSTRACT

Neuromodulation assemblies with lead bodies having curvatures that mimic the curvatures of the splenium, trunk, genu, or rostrum of the corpus callosum. Methods of stimulating the corpus callosum and methods of securing an electrical lead in the brain are also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of application Ser. No.11/121,057 filed on May 4, 2005, which issued as U.S. Pat. No.7,725,196, and which claims priority to U.S. Provisional ApplicationSer. Nos. 60/608,417 filed on Sep. 10, 2004, 60/608,418, filed on Sep.10, 2004 and 60/567,441, filed on May 4, 2004, all of which are hereinincorporated by reference in their entirety.

FIELD OF THE INVENTION

The present invention is directed to a neuromodulation assembly forstimulating neural tissue.

BACKGROUND OF THE INVENTION

Electrical stimulation of neural tissue is becoming an increasinglypreferred form of therapy for various neurological conditions anddisorders. Such therapy provides distinct advantages over surgicallesioning techniques since electrical stimulation is a reversible andadjustable procedure that provides continuous benefits as the patient'sdisease progresses and the patient's symptoms evolve.

Currently, electrical stimulation of peripheral nerves and the spinalcord is approved for treatment of neuropathic pain. With respect to deepbrain targets, electrical stimulation of the subthalamic nucleus and theglobus pallidus interna is approved for treatment of Parkinson's diseaseand electrical stimulation of the ventral intermediate nucleus isapproved for treatment of essential tremor.

There remains a need for further forms of neuromodulation and devices toaccomplish the same.

SUMMARY OF THE INVENTION

In an embodiment, the present invention provides a neuromodulationassembly comprising a lead body having a top surface and a bottomsurface. The lead body has a curvature that mimics the curvature of thetrunk, the genu, the splenium, or the rostrum of the corpus callosum inan operative position of the lead body. The neuromodulation assemblyfurther comprises an electrical contact exposed at the bottom surfaceand not the top surface of the lead body, a conductor coupled to theelectrical contact and extending from the lead body, and an anchordisposed on the conductor.

In an embodiment, the present invention provides a neuromodulationassembly comprising a lead body having a top surface and a bottomsurface. The lead body has a curvature that mimics the curvature of thetrunk, the genu, the splenium, or the rostrum of the corpus callosum inan operative position of the lead body. The neuromodulation assemblyfurther comprises an electrical contact exposed at the bottom surfaceand not the top surface of the lead body, a conductor coupled to theelectrical contact and extending from the lead body, an accessory strandextending from the lead body, and an anchor disposed on the accessorystrand.

In an embodiment, the present invention provides a method of stimulatingthe corpus callosum comprising placing an electrical lead having anelectrode disposed thereon in communication with a corpus callosum andactivating the electrode to apply an electrical signal to the corpuscallosum to stimulate the corpus callosum.

In an embodiment, the present invention provides a method of securing anelectrical lead comprising a lead body having an electrode disposedthereon. The method comprises anchoring the lead to the dura mater ofthe brain.

BRIEF DESCRIPTION OF THE INVENTION

The present invention will become more fully understood from thedetailed description given hereinbelow and the accompanying drawingswhich are given by way of illustration only and wherein:

FIG. 1 depicts a sagittal section of the brain showing the corpuscallosum.

FIG. 2 is a perspective view of an embodiment of a neuromodulationassembly according to the present invention.

FIG. 3 is a bottom view of a neuromodulation assembly according to thepresent invention.

FIG. 4 depicts an embodiment of a neuromodulation assembly according tothe present invention positioned on the trunk of the corpus callosum.

FIG. 5 depicts an embodiment of a neuromodulation assembly according tothe present invention positioned on the genu of the corpus callosum.

FIG. 6 depicts an embodiment of a neuromodulation assembly according tothe present invention positioned on the rostrum of the corpus callosum.

FIG. 7 depicts an embodiment of a neuromodulation assembly according tothe present invention positioned on the splenium of the corpus callosum.

FIG. 8 depicts a lead body of the present invention in a pre-operativeposition.

FIG. 9 depicts an alternative embodiment of a neuromodulation assemblyaccording to the present invention.

FIG. 10 depicts a neuromodulation kit according to an embodiment of thepresent invention.

FIG. 11 depicts a neuromodulation assembly of the present inventionwherein the lead body is in a pre-operative position inside a cannula.

FIG. 12 depicts the neuromodulation assembly of FIG. 11 wherein the leadbody is shown exiting the distal end of the cannula.

FIG. 13 is a sagittal section of the brain illustrating a cylindricallead that is positioned within the corpus callosum along thelongitudinal axis thereof

FIG. 14 is a diagrammatic view of a patient in which an embodiment of aneuromodulation assembly has been implanted.

FIG. 15 depicts a neuromodulation assembly wherein the lead body is onthe bottom surface of the trunk of the corpus callosum.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides embodiments of electrical lead assembliesfor neuromodulation of the corpus callosum. Referring to FIG. 1 and asis known to one of skill in the art, the corpus callosum 10 is locatedbetween the hemispheres in the floor of the interhemispheric fissure andthe roof of the lateral ventricles. The corpus callosum 10 has twoanterior parts, the rostrum 20 and the genu 30, a central part, thetrunk 40 (also referred to as the body of the corpus callosum), and aposterior part, the splenium 50. The anterior parts 20 and 30 aresituated in the midline deep to the upper part of the inferior frontalgyms. As illustrated in FIG. 1, the genu 30 blends below into therostrum 20, which is thin and tapered. Rostrum 20 is continuous downwardin front of the anterior commissure, with the lamina terminalis. Thecurved genu 30 wraps around and forms the anterior wall and adjacentpart of the roof of the frontal horn as it extends obliquely forward andlateral to connect the frontal lobes. As illustrated in FIG. 1, the genu30 blends posteriorly into the trunk 40, located above the body of thelateral ventricle. The genu 30 and the trunk 40 of the corpus callosum10 form the roof of both the frontal horn and the body of the lateralventricle. The splenium 50 is situated deep to the supramarginal gymsand the lower third of the pre-and postcentral gyri. As illustrated inFIG. 1, the splenium 50 is the thick rounded posterior end of the corpuscallosum 10 and is situated dorsal to the pineal body and the upper partof the medial wall of the atrium. The splenium 50 contains a fibertract, the forceps major, which forms a prominence, called the bulb, inthe upper part of the medial wall of the atrium and occipital horn as itextends posteriorly to connect the occipital lobes. The cingulate gymssurrounds and is separated from the corpus callosum 10 by the callosalsulcus. Further description of the corpus callosum 10 are described inRhoton, Albert, L. Jr. M.D. The Lateral and Third Ventricles.Neurosurgery 51(4) SUPPLEMENT 1: S1-207-271 (October 2002); Rhoton,Albert L. Jr. M.D. The Cerebrum. Neurosurgery. 51(4) SUPPLEMENT 1:S1-1-52 (October 2002), both of which are incorporated by referenceherein.

Referring to FIGS. 2-7, embodiments of the present invention provide aneuromodulation assembly 60 comprising a lead body 70 having a topsurface 80 and a bottom surface 90. As used herein, the terms “top,”“bottom,” and “under-surface” are defined relative to the operativeposition of lead body 70 of neuromodulation assembly 60. As used herein,the term “operative position” refers to the position of lead body 70when lead body 70 is positioned on the target region of the corpuscallosum 10 and neuromodulation assembly 60 is ready to be activated toinitiate therapy to the target region of the corpus callosum 10. Asreferred to herein, the “target region of the corpus callosum” is thetrunk, genu, rostrum, or splenium of the corpus callosum. Referring toFIG. 3, an electrical contact 100 from an electrode, and preferably aplurality (i.e. more than one) of electrical contacts 100 from one orfrom a plurality of respective electrodes, is exposed at the bottomsurface 90 of lead body 70. Top surface 80, however, is insulated suchthat no electrical contact is exposed at top surface 80. Referring againto FIG. 2, neuromodulation assembly 60 further comprises a conductor 110that is coupled to an electrode having an electrical contact 100.Conductor 110 extends from lead body 70 to directly or indirectly beconnected to an implantable pulse generator. To this end, conductor 110of neuromodulation assembly 60 may further comprise a connector 125 toconnect to a mating connector of an extension lead, which in turn isconnectable to an implantable pulse generator. Neuromodulation assembly60 further comprises an anchor 115, and preferably a plurality ofanchors 115, which in the embodiment depicted in FIG. 2, is disposed onconductor 110.

The present invention provides embodiments of lead body 70 that eachhave a curvature that mimics the curvature of a target region of thecorpus callosum 10. Specifically, referring to FIG. 4, in an embodiment,lead body 70 has a curvature that mimics the curvature of the trunk 40of the corpus callosum 10 in an operative position of lead body 70.Referring to FIG. 2, in such an embodiment, conductor 110 preferablyextends from substantially the center of lead body 70. Referring to FIG.5, in another embodiment, lead body 70 has a curvature that mimics thecurvature of the genu 30 of the corpus callosum 10 in an operativeposition of lead body 70. Referring to FIG. 6, in another embodiment,lead body 70 has a curvature that mimics the curvature of the rostrum 20of the corpus callosum 10 in an operative position of lead body 70.Referring to FIG. 7, in yet another embodiment, lead body 70 has acurvature that mimics the curvature of the splenium 50 of the corpuscallosum 10 in an operative position of lead body 70. In the embodimentsdepicted in FIGS. 5-7, conductor 110 preferably extends from one of theside ends of lead body 70.

The trunk 40, the genu 30, the rostrum 20, and the splenium 50 of thecorpus callosum 10 are described above and are well-definedneuroanatomical sites. Therefore, the curvatures of these regions arewell known to one of ordinary skill in the art. Because the curvaturesof lead bodies 70 of these embodiments of the present invention mimicthe curvatures of these regions, such curvatures of lead bodies 70 willalso be well-understood by one of skill in the art. In general, inembodiments where lead body 70 mimics the curvature of the trunk 40 orthe rostrum 20, lead body 70 has a cambered configuration. Inembodiments where lead body 70 mimics the curvature of the splenium 50,lead body 70 has a generally J-shaped configuration. As used herein, thephrase “mimics the curvature” encompasses configurations of lead body 70that not only conform to the general curvature of a target region of thecorpus callosum 10 but also follow the general curvature of therespective target region of the corpus callosum 10 such that lead body70 grasps such region to allow for a more secure fit of the lead body 70on such region.

With respect to specific details of neuromodulation assembly 60, asdescribed above, neuromodulation assembly 60 further comprises an anchor115 for securing lead body 70 in the brain. As illustrated in FIG. 2, inan embodiment, anchor(s) 115 is disposed on conductor 110. Referring toFIG. 9, in an alternative embodiment, neuromodulation assembly 60comprises an accessory strand 120, or a plurality of accessory strands120 as specifically illustrated in FIG. 9, which extends from lead body70 and has an anchor 115 disposed thereon. In the case of a plurality ofaccessory strands 120, each accessory strand 120 has at least one anchor115 disposed thereon. In either embodiment, anchor 115 is preferablyslidably disposed on conductor 110 or accessory strand 120 so thatanchor 115 can be appropriately moved along the longitudinal axis ofconductor 110 or accessory strand 120 to be positioned adjacent thedesired anchoring site of the brain. Anchor 115 may be any structureknown in the art that is suitable for anchoring lead body 70 in thebrain. Non-limiting examples of anchor 115 include a tine, hook, suturesleeve, or twist-lock as described in U.S. Pat. No. 5,843,146, which isincorporated by reference herein.

As mentioned above, electrical contacts 100 of electrodes are exposed atthe bottom surface 90 of lead body 70. Preferably, such electrodes areadjustably powerable. For example, the pulsing parameters of theelectrodes may be adjusted to initiate, stop, increase, or decrease thepole combinations, energy, amplitude, pulse width, waveform shape,frequency, and/or voltage or any other pulsing parameter known to one ofskill in the art to adjust the degree of stimulation delivered thereby.In a preferred embodiment, each electrode is selectively powerable suchthat the pulsing parameters of an electrode can be adjusted independentof the pulsing parameters of another electrode.

Referring to FIG. 14, the selective powerability over each electrode maybe achieved by employing a system including a programmer 520 coupled viaa conductor 530 to a telemetry antenna 540. The programmer 520 iscapable of sending signals via the telemetry antenna 540 to control theelectrical signal delivered to electrodes. Such a system permits theselection of various pulse output options after the neuromodulationassembly 60 is implanted using telemetry communications. The presentinvention also contemplates radio-frequency systems to selectively powerthe electrodes.

As will be understood by one of skill in the art, the independentpowerability of the electrodes also provides a practitioner with a meansof modifying or steering the direction of stimulation as the locus ofstimulation can be selectively adjusted to precisely target portions ofthe target region of the corpus callosum 10 to achieve the desiredtherapy. For example, with reference to FIG. 3, electrode havingelectrical contact 100 a may be powered to stimulate an area adjacentthereto while the signal to the electrode having electrical contact 100e may be substantially minimized to reduce or stop stimulation to anarea adjacent to electrical contact 100 e. Because the locus ofstimulation can be selectively adjusted and/or steered in thisembodiment of neuromodulation assembly 60, specific areas of the targetregions of the corpus callosum can be precisely targeted to achieve thedesired therapy. Other or additional means of selectively steeringelectrical stimulation may also be utilized in the present invention,such as the methods described in U.S. Pat. No. 5,713,922, which isincorporated by reference herein.

In a preferred embodiment, lead body 70 is fabricated from a flexiblematerial that is deformable from a pre-operative position to theoperative position and is configured to retain its shape when in theoperative position. In a pre-operative position, illustrated in FIG. 8,lead body 70 is folded at an angle sufficient to clear the superficiallevels of the brain above the corpus callosum 10, such as the venouscomplexes and superior sagittal sinus upon entry into the brain. Oncelead body 70 reaches the corpus callosum, lead body 70 can unfold andassume the operative position on the trunk, genu, rostrum, or spleniumof the corpus callosum. In such embodiments, the flexible material oflead body 70 may comprise, for example, a rubber, a shape memory alloysuch as nickel-titanium alloys (“Nitinol”) and copper based alloys, or asuperelastic material.

Referring back to FIG. 2, top surface 80 of lead body 70 may comprise afastener 135 or a plurality of fasteners 135 that cooperates withportions of an installation tool to secure an installation tool to leadbody 70. Non-limiting examples of suitable fasteners 135 include astrap, buckle, a groove, a through-hole, or a snap. In general, anyfastening mechanism may be used to secure an installation tool to leadbody 70 such as, for example, a hook-and eye mechanism, a hook and loopmechanism such as that employed under the tradename VELCRO, clamps,staples, and any type of male-female mating members such as nuts andscrews, rivets, and the like. Referring to FIG. 10, in anotherembodiment, the present invention provides a neuromodulation kitcomprising an neuromodulation assembly 60 having a lead body 70including a pair of fasteners 135 (illustrated in FIG. 2) and aninstallation tool 130 having a proximal portion 140 comprising a handle150 and a distal portion 160 comprising a pair of arms 170 a and 170 bthat are connected to one another by a first pivot 180. Arms 170 a and170 b have distal ends configured to releasably cooperate with fasteners135 of lead body 70. In the embodiment depicted in FIG. 10 (and FIG. 2),fasteners 135 are grooves that receive the distal ends of arms 170 a and170 b, such distal ends being flared to prevent disengagement fromfasteners 135. Of course, other fastening mechanisms well-known to oneof skill in the art can be used to secure distal ends of arms 170 a and170 b to lead body 70. For example, fasteners 135 can comprise malefasteners and the distal ends of arms 170 can have female fastenersattached thereto or integral therewith that act in cooperation with themale fasteners of lead body 70 to secure installation tool 130 to leadbody 70. Referring further to FIG. 10, installation tool 130 may furthercomprise a second pivot 190 located proximal to first pivot 180connecting arms 170 a and 170 b.

The present invention also provides a corpus callosum neuromodulationsystem including neuromodulation assembly 60 and further includingcomponents useful in identifying, monitoring, or affecting a targetregion of the corpus callosum 10. For example, such a system couldinclude a component for lesioning and temperature monitoring, and/or acomponent that has a fiberoptic monitor which allows telemetricintracranial monitoring capabilities, and/or a microelectrode recordingcomponent, and/or a sensing component to incorporate a feedbackmechanism to assist in determining whether lead body 70 should beadjusted. With respect to a sensing component, referring to FIG. 14, asensor 550 can be incorporated with the corpus callosum electricalstimulation system according to the present invention. Sensor 550 can beused with a closed-loop feedback system in order to automaticallydetermine the level of stimulation necessary to provide the desiredtherapy. Sensor 550 may be implanted into a portion of a patient P'sbody suitable for detecting characteristics, symptoms or attributes ofthe condition or disorder being treated such as electrical brainactivity, cerebral blood flow, and/or vital signs or other chemical andelectrical activity of the body. Sensors suitable for use in a systemaccording to the present invention include, for example, those disclosedin U.S. Pat. No. 5,711,316, which is incorporated by reference herein.In cases where the attribute of the symptom is the electrical activityof the brain, stimulating electrodes may be intermittently used torecord electrical activity. Alternatively, one or more electrodesimplanted within the brain may serve as a sensor or a recordingelectrode. When necessary, these sensing or recording electrodes maydeliver stimulation therapy to the target region of the corpus callosum.The output of an external feedback sensor may communicate with animplanted pulse generator through a telemetry down-link. Any sensingfunctions in accordance with the present invention can be performedlocally, distally, or remotely from the target site and the presentinvention also contemplates use of neuromodulation assembly 60integration with imaging methods known in the art such as X-rays,computer tomography, magnetic resonance imaging, and functional magneticresonance imaging.

In an exemplary method of using an neuromodulation assembly 60 of thepresent invention, a patient is positioned on the operating table in thesupine position under general endotracheal anesthesia. The patient'shead is immobilized using a pin head holder. An incision is made on skinof the skull, in one of several fashions: frontotemporal, bifrontal,frontal, frontotemporoparietal or other. After the skip flap isretracted, a frontal-parietal craniotomy is performed passing themidline to expose the superior sagital sinus. Alternatively, othercraniotomies can also be made, such as a bifrontal craniotomy,frontotemporo craniotomy, frontotemporoparietal craniotomy, craniotomiesextended to the controlateral side and other variations. The dura materis tacked to the skull and opened in an arc with the dura mater's basetoward the midline. Dissection is continued until the interhemisphericfissure is adequately exposed at the level of the falx. Theinterhemispheric fissure is dissected using microneurosurgicaltechniques known to one of skill in the art. The interhemisphericfissure is dissected until the corpus callosum is adequately exposed.The branches of the anterior communicating artery may be dissected awayto create necessary area to implant an neuromodulation assembly 60 ofthe present invention.

Neuromodulation assembly 60 is then delivered to the surface of corpuscallosum 10 by any appropriate method known in the art. For example, asillustrated in FIG. 10, an installation tool may be used which grips andfolds lead body 70 into the pre-operative position and then delivers andplaces lead body 70 in the operative position on the target region ofthe corpus callosum 10.

Referring to FIG. 11, neuromodulation assembly 60 may also be deliveredto the corpus callosum 10 via a cannula 200. In such a case, lead body70 is folded and inserted into cannula 200 and delivered to the corpuscallosum 10. Referring to FIG. 12, as lead body 70 exits the distal endof cannula 200, lead body 70 unfolds and can assume the operativeposition on the corpus callosum 10. To assist in preventing unnecessarylateral movement or rotation of lead body 70 as it travels down cannula200 and exits the distal end thereof, cannula 200 may include a guidefrom which lead body 70 depends, or tracks that direct lead body 70 inan outwardly direction away from cannula 200, when lead body 70 isadvanced out of the distal end of cannula 200.

Of course, other methods of delivering and implanting neuromodulationassembly 60, including using conventional neurosurgical instrumentation,are within the knowledge of one of skill in the art and theneuromodulation assembly 60 is not limited to delivery by any particularmethod. For example, lead body 70 can be delivered by any minimallyinvasive technique such as endoscopically and/or intravascularly.Referring to FIG. 15, neuromodulation assembly 60 can be delivered tothe target region of the corpus callosum, such as the trunk 40,neuroendoscopically through the lateral ventricle such that lead body 70is in contact with the under surface 71 of the trunk 40 of the corpuscallosum 10.

Once lead body 70 is placed on the target region of the corpus callosum10, neuromodulation assembly 60 is anchored in the brain by securinganchor 115 to the dura mater of the falx and/or the dura mater of theconvexity, for example. Closure of the craniotomy can be performed usingstandard methods well-known to one of skill in the art. A tunnelingdevice can then be used to dissect a subcutaneous tunnel down to thesubclavicular level, where a subcutaneous pocket can be made toaccommodate an implantable pulse generator. An extension wire can thenbe passed through the tunnel to connect the neuromodulation assembly tothe pulse generator. Alternatively, other sites can be used forimplantation of the pulse generator, such as the abdominal wall and thelower back area below the posterior iliac crest.

After implantation, the electrodes of lead body 70 may be adjustedpost-operatively by turning them on or off, adjusting the voltage,adjusting the frequency, and adjusting other electrical signalparameters through the use of telemetry, RF signals, or other systemsknown in the art. Those skilled in the art will appreciate thatelectrical properties of the electrodes and the resulting electricalfield may be varied by selectively powering individual or groups ofelectrodes formed from or controlled by micro-electrical mechanicalsystems (MEMS). Moreover, MEMS actuators may drive electrodes, drugdelivery catheters, sensing probes, and the like from the cannula todesired locations in an area of interest.

Neuromodulation assembly 60 may also be implemented within a drugdelivery system to provide chemical stimulation utilizing a drug,pharmaceutical, or therapeutic agent. In this embodiment, the signalgenerator is replaced with or includes a pump and the electrodes arereplaced with a catheter or drug ports. The pump may be implanted belowthe skin of a patient and has a port into which a hypodermic needle canbe inserted through the skin to inject a quantity of a liquid, such as adrug, pharmaceutical, or therapeutic agent. The liquid agent isdelivered from a pump through a catheter port into a catheter. Thecatheter is positioned to deliver the liquid agent to specific infusionsites in the brain. Alternatively, neuromodulation assembly 60 may becombined with a drug delivery system to provide both chemical andelectrical modulation to target regions of the corpus callosum.

In another embodiment, the present invention provides a method ofstimulating the corpus callosum 10 by placing an electrode lead havingan electrode disposed thereon and preferably a plurality of electrodes,in communication with the corpus callosum 10. The method furthercomprises activating the electrode to apply an electrical signal to thecorpus callosum 10 to stimulate the corpus callosum 10. Referring toFIG. 13, the electrical lead can penetrate the thickness 113 of thecorpus callosum along the longitudinal axis thereof. Alternatively, theelectrical lead can be placed on the top surface 111 or the bottomsurface 112 of the corpus callosum. The electrical lead, according tothis method, may be any electrical lead that is configured to stimulatethe corpus callosum. For example, the electrical lead can beneuromodulation assembly 70 according to the present invention or anyother suitable lead, such as a cylindrical lead 210, as illustrated inFIG. 13, which penetrates the corpus callosum 10 along the longitudinalaxis thereof. In such an embodiment, cylindrical lead 210 having anelectrode, and preferably a plurality of electrodes, disposed thereoncan be inserted in the brain and into the corpus callosum through acannula guided by a stereotactic apparatus. A conductor coupled toelectrical contact and extending from lead 210 can be anchored to theskull via a burr hole anchoring device. Alternatively, cylindrical lead210 can be anchored to dura mater, as described above with respect toneuromodulation assembly 60.

In another embodiment, the present invention provides a method ofsecuring in the brain an electrical lead comprising a lead body havingan electrode, and preferably a plurality of electrodes, disposedthereon. The method comprises anchoring the electrical lead to the duramater of the brain, such as the dura mater of the convexity or the falx.Such an anchoring method may be a preferred method of anchoring anelectrical lead in electrical neuromodulation procedures where the leadis positioned on the surface of the target site rather than penetratingthe target site. For example, such a method may be used to anchordevices that stimulate structures in the brain that are located incisterns, such as the basal cisterns, or superficial structures, such asthe surface of the cerebellum, or the sylvian fissure.

The foregoing description and examples have been set forth merely toillustrate the invention and are not intended as being limiting. Each ofthe disclosed aspects and embodiments of the present invention may beconsidered individually or in combination with other aspects,embodiments, and variations of the invention. In addition, unlessotherwise specified, none of the steps of the methods of the presentinvention are confined to any particular order of performance.Modifications of the disclosed embodiments incorporating the spirit andsubstance of the invention may occur to persons skilled in the art andsuch modifications are within the scope of the present invention.Furthermore, all references cited herein are incorporated by referencein their entirety.

We claim:
 1. A neuromodulation assembly comprising: a lead body having atop surface and a bottom surface, the lead body having a curvature thatmimics the curvature of the trunk, genu, splenium, or rostrum of thecorpus callosum in an operative position of the lead body; an electricalcontact exposed at the bottom surface and not the top surface of thelead body; a conductor coupled to the electrical contact and extendingfrom the lead body; an accessory strand extending from the lead body;and an anchor disposed on the accessory strand.
 2. The neuromodulationassembly of claim 1, wherein the lead body has a curvature that mimicsthe curvature of the trunk of the corpus callosum in an operativeposition of the lead body.
 3. The neuromodulation assembly of claim 1,wherein the conductor extends from substantially the center of the leadbody.
 4. The neuromodulation assembly of claim 1, wherein the lead bodyhas a curvature that mimics the curvature of the rostrum of the corpuscallosum in an operative position of the lead body.
 5. Theneuromodulation assembly of claim 1, wherein the lead body has acurvature that mimics the curvature of the splenium of the corpuscallosum in an operative position of the lead body.
 6. Theneuromodulation assembly of claim 1, wherein the lead body has acurvature that mimics the curvature of the genu of the corpus callosumin an operative position of the lead body.
 7. The neuromodulationassembly of claim 1, wherein the lead body is fabricated from a flexiblematerial and is deformable from a pre-operative position to theoperative position and is configured to retain its shape when in theoperative position.
 8. The neuromodulation assembly of claim 7, whereinthe material is a shape memory alloy.
 9. The neuromodulation assembly ofclaim 1, wherein the anchor comprises a plurality of anchors.
 10. Theneuromodulation assembly of claim 1, wherein the anchor is selected fromthe group consisting of: a tine, a hook, and a suture sleeve.
 11. Theneuromodulation assembly of claim 1, wherein the anchor is slidablydisposed on the accessory stand.
 12. The neuromodulation assembly ofclaim 1, wherein the lead body further comprises a fastener.
 13. Theneuromodulation assembly of claim 12, wherein the fastener comprises apair of fasteners.
 14. An electrical stimulation kit comprising theneuromodulation assembly of claim 13, and further comprising aninstallation tool having a proximal portion comprising a handle and adistal portion comprising a pair of arms that are connected by a firstpivot, the pair of arms having distal ends configured to releasablycooperate with the pair of fasteners of the lead body.
 15. Theelectrical stimulation kit of claim 14, wherein the installation toolfurther comprises a second pivot connecting the pair of arms, the secondpivot located proximal to the first pivot.
 16. The electricalstimulation kit of claim 14, wherein the pair of fasteners of the leadbody comprise male fasteners and the distal ends of the pair of armscomprise female fasteners, the male and female fasteners acting incooperation with each other to secure the installation tool to the leadbody.
 17. The neuromodulation assembly of claim 12, wherein the fastenercomprises a male fastener for cooperation with a female fastener. 18.The neuromodulation assembly of claim 12, wherein the fastener comprisesa strap, a groove, a buckle, a through-hole, or a snap.
 19. Theneuromodulation assembly of claim 1, wherein the accessory strandcomprises a plurality of accessory strands.
 20. The neuromodulationassembly of claim 19, wherein each of the plurality of accessory strandshas at least one anchor disposed thereon.
 21. The neuromodulationassembly of claim 1, wherein the curvature is a preset curvature whichthe lead body is configured to retain.
 22. The neuromodulation assemblyof claim 1, wherein the lead body has a J-shaped curvature in theoperative position of the lead body.
 23. The neuromodulation assembly ofclaim 1, wherein the lead body has a cambered curvature in the operativeposition of the lead body.
 24. A method of stimulating a corpuscallosum, the method comprising: placing an electrical lead having anelectrode disposed thereon in communication with a corpus callosum; andactivating the electrode to apply an electrical signal to the corpuscallosum to stimulate the corpus callosum; wherein: the electrical leadcomprises: a lead body that includes a top surface, a bottom surface,and a curvature that mimics a curvature of the trunk, genu, splenium, orrostrum of the corpus callosum in an operative position of the leadbody; and an electrical contact exposed at the bottom surface and notthe top surface of the lead body; a conductor is coupled to theelectrical contact and extends from the lead body; an accessory strandextends from the lead body; and an anchor is disposed on the accessorystrand.
 25. The method of claim 24, wherein the electrode comprises aplurality of electrodes.
 26. The method of claim 24, wherein theelectrical lead penetrates the corpus callosum.
 27. The method of claim24, wherein the electrical lead is delivered to the corpus callosumintravascularly.
 28. The method of claim 24, wherein the corpus callosumincludes an under-surface and the electrical lead is placed on theunder-surface of the corpus callosum.
 29. A method of securing in thebrain an electrical lead, the method comprising: anchoring theelectrical lead to the dura mater of the brain; wherein: the electricallead comprises: a lead body that includes a top surface, a bottomsurface, and a curvature that mimics a curvature of the trunk, genu,splenium, or rostrum of the corpus callosum in an operative position ofthe lead body; and an electrical contact exposed at the bottom surfaceand not the top surface of the lead body; a conductor is coupled to theelectrical contact and extends from the lead body; an accessory strandextends from the lead body; and an anchor is disposed on the accessorystrand.
 30. The method of claim 29, wherein the dura mater is the duramater of the convexity.
 31. The method of claim 29, wherein the duramater is the dura mater of the falx.